Evaluation of the garlic extract (Allium sativum) effect to improving fatigue and quality of life in patients with multiple sclerosis (MS) a randomized, placebo-controlled clinical trial
Evaluation of the garlic extract (Allium sativum) effect to improving fatigue and quality of life in patients with multiple sclerosis (MS)
Design
clinical trial with control group, parallel groups, double-blind, randomized
Settings and conduct
This study will be performed in the MS clinic of Al-Zahra Hospital and Ayatollah Kashani Hospital affiliated to Isfahan University of Medical Sciences. For the drug group, garlic tablets (produced by Amin Pharmaceutical Company called Garlet, which contains 400 mg of garlic extract powder and standardized based on 1200 micrograms of allicin and equivalent to 2 grams of fresh garlic) at a dose of 400 mg every 12 hours for 4 weeks and For people in the placebo group, the placebo pill (produced by the same company with the same shape and packing) will be prescribed with the same frequency and duration. Patients in both groups will receive their standard treatment according to the opinion and prescription of the plan's doctor (neurologist). Patients will fill in the questionnaires before the start and end of the study.
Participants/Inclusion and exclusion criteria
Age over 18 years/ Relapsing-remitting MS/ At least 6 months have passed since the diagnosis/ Advanced Disability Status Scale (EDSS) ≤ 5/ Complaints of obvious fatigue
No entry: Pregnancy/ Breastfeeding/ Diseases causing fatigue/ Having diseases that cause fatigue such as diabetes/ Use of psychotropic drugs, effective antidepressants
Intervention groups
Drug group : Garlic tablets (produced by Amin Pharmaceutical Company called Garlet, which contains 400 mg of garlic extract powder and standardized based on 1200 micrograms of allicin and equivalent to 2 grams of fresh garlic) at a dose of 400 mg every 12 hours for 4 weeks
Placebo group: Placebo tablets (produced by the same company with similar shape and packaging)
Main outcome variables
severity of fatigue and increase life quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N15
Registration date:2021-03-01, 1399/12/11
Registration timing:retrospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-29, 1399/09/09
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the garlic extract (Allium sativum) effect to improving fatigue and quality of life in patients with multiple sclerosis (MS) a randomized, placebo-controlled clinical trial
Public title
The effect of garlic on fatigue and quality of life in MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Relapsing-remitting MS
At least 6 months have passed since the diagnosis
Complaints of obvious fatigue
Block randomization method using blocks of size 4 will be used. So that all possible sequences of two drug and two placebo in each block will be made with each block being numbered. Then, using random number table, the blocks will be selected randomly and the patients will be assigned to the two groups of drug and placebo according to the the blocks sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, the prescribing physician and the data analyst will be blind to the intervention type. The drug and placebo will be prepared in similar coded bottles and given to the chief researcher. A bottle will be given to each patient according to the chief researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-07-10, 1399/04/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.420
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
fatigue severity
Timepoint
Before and after the intervention
Method of measurement
fatigue severity sacle (fss)
2
Description
Quality of life
Timepoint
Before and after the intervention
Method of measurement
The Short Form Health Survey (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Allium 400-mg tablets (manufactured by Amin company), every 12 hours, for 4 weeks
Category
Treatment - Drugs
2
Description
Placebo group: Placebo tablets (manufactured by Amin company), every 12 hours, for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
MS clinic of Al-Zahra hospital
Full name of responsible person
Rasool Soltani
Street address
Soffeh Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
2
Recruitment center
Name of recruitment center
clinic of Ayatollah Kashani Hospital
Full name of responsible person
Rasool Soltani
Street address
Kashani St
City
Isfahan
Province
Isfehan
Postal code
۸۳۴۳۴۸۱۸۳۹
Phone
+98 31 3233 0091
Email
soltani@pharm.mui.ac.ir
Web page address
https://kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar-Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174683461
Phone
+98 31 3792 3071
Email
research@mui.ac.ir
Web page address
http://mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD